SBS - The best value in QMS software

Requirements relating to Serial Number and Lot Number

Sue789

Involved In Discussions
#1
Where can I find the requirements of when to use a serial number against a lot number? The parts have no electrical components, not sterilized do not require servicing or installation. Have a use life of six months.

I am working with a Company who is placing three serial numbered parts into one box for shipping. We outsource manufacturing and we distribute the product. At the moment our Warehouse is opening the boxes to find out what serial numbers enclosed. Our subcontractor is unhappy to print another bar code to add to the outside of the box.

We currently have both serial number and lot numbers on the device which is housed in a plastic injection moulded case and contains a dial gauge (no serial number) which is not calibrated and connected to an oxygen supply.

Thanks in advance.
Sue
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
The extent of identification & traceability measures you need to employ is tied to risk.
Does your device have any of the following characteristics?:
1. Implantable?
2. Intended to support or sustain life?
3. Failure would reasonable expect to result in significant injury?

If none of the above, the traceability you institute is up to your own risk-assessment.

Also, it's not totally clear as to the system you describe. Do I have this right:
1. Device includes 3 serialized parts that you do not label (they are labelled by the manufacturer), and additionally, the box they are packaged in has an identifier (also included by the manufacturer)?
2. This box is then included in a plastic case, along with a dial and oxygen-supply, which you label with a serial number and lot?
 

Sue789

Involved In Discussions
#3
Thanks for your reply.

The device has none of the characteristics listed above. I am new to the Company and I could not understand why the product required a label and it is my suggestion to remove it after we did an initial risk analysis on the product. Our manufacturer is prepared to lots of 50 which is sufficient for traceability.

The product is labelled with a serial number, lot number and bar code and placed in a box with the same details. These are then packaged in threes and the manufacture is not willing to stick a barcode with the serial numbers on the outside of the shipping box so our Goods-Inwards have to open all the boxes. Which as this is a new product is something we are trying to stop.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Just a quick note that it's very important to state where it all happens, for regulatory compliance.
- Where is the OEM located?
- Where are the devices initially sent to (receiving warehouse of the OBL)?
- In what market are the devices to be placed by the OBL?

When I say "where" I mean in what regulatory geographical domain (EU, USA etc.).
 

Sue789

Involved In Discussions
#5
Thanks for the reply all companies are based in the U.K.

We ship worldwide- USA, Europe, Japan South America, Middle Eat etc.b
 

Mark Meer

Trusted Information Resource
#7
The device has none of the characteristics listed above. I am new to the Company and I could not understand why the product required a label and it is my suggestion to remove it after we did an initial risk analysis on the product. Our manufacturer is prepared to lots of 50 which is sufficient for traceability.
From what you describe, I'd agree with this assessment.

It sounds like the parts received would be part of your purchasing and supplier control processes, and so I don't see why you'd have to maintain documentation of the serial numbers of all the parts received.

If you maintain purchasing records, and the supplier, in turn, has their own lot/distribution records (presumably as part of an established quality system), then I don't see any reason why you'd have to open every box just to record the serial numbers.
 
Thread starter Similar threads Forum Replies Date
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
A Legal and Other Requirements Relating to Objectives and Targets Miscellaneous Environmental Standards and EMS Related Discussions 12
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
J Requirements for registering Alcohol Wipes (70% IPA) in Canada Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
G MDR translation requirements EU Medical Device Regulations 3
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom